Cynet Systems
Job Description:
Pay Range: $54.9hr - $57.9hr
The technical writer develops and authors Chemistry, Manufacturing, and Controls (CMC) Common Technical Documents (CTD) for development and post-approval regulatory dossiers within set timelines. Responsibilities include preparing responses to health authority inquiries, amendments, supplements, variations, and annual reports. The technical writer also authors and evaluates change controls for global regulatory impact and may prepare technical reports, position papers, XX papers, or SOPs. This role requires ensuring regulatory dossier compliance and independently authoring high-quality CMC content while following regulatory guidelines, source documentation, and templates. The technical writer collaborates with key stakeholders across business units, contract manufacturing organizations, and functional teams such as Quality, Manufacturing, and Global Regulatory Affairs. dditional responsibilities include supporting regulatory risk mitigation strategies, maintaining current regulatory knowledge, and supporting planning and timeline preparation. Requirement/Must Have:
CMC and CTD authoring experience (Modules 2 and 3). t least five years of experience in the pharmaceutical industry. Experience with document management systems such as Veeva or Documentum (preferred). Working knowledge of cGMPs. Experience with MS Office applications. Excellent interpersonal communication skills. bility to work independently with minimal supervision. Strong organization skills, attention to detail, and self-motivation. Experience:
Experience in pharmaceutical manufacturing or quality control/quality assurance (preferred). Experience with small molecules and some aseptically manufactured products. Medical device experience (preferred). Responsibilities:
Develop and author CMC CTD documents for regulatory submissions. Prepare responses to health authority inquiries and regulatory updates. uthor and evaluate change controls for global regulatory impact. Create technical reports, position papers, XX papers, or SOPs. Ensure regulatory dossier compliance. Collaborate with cross-functional stakeholders and CMOs. Support regulatory risk mitigation strategies. Maintain updated knowledge of SOPs, regulatory guidelines, and ways of working. ssist in planning and timeline preparation. Should Have:
bility to work collaboratively across multidisciplinary teams. Strong communication and stakeholder coordination skills. Skills:
Expertise in CMC and CTD documentation. Knowledge of Veeva or Documentum. Understanding of cGMPs. Strong organizational and writing skills. bility to analyze and interpret regulatory requirements. Qualification And Education:
BS/BA, MS, or PhD in a science or health field such as Biology, Analytical Chemistry, Pharmacy, or a related discipline.
Pay Range: $54.9hr - $57.9hr
The technical writer develops and authors Chemistry, Manufacturing, and Controls (CMC) Common Technical Documents (CTD) for development and post-approval regulatory dossiers within set timelines. Responsibilities include preparing responses to health authority inquiries, amendments, supplements, variations, and annual reports. The technical writer also authors and evaluates change controls for global regulatory impact and may prepare technical reports, position papers, XX papers, or SOPs. This role requires ensuring regulatory dossier compliance and independently authoring high-quality CMC content while following regulatory guidelines, source documentation, and templates. The technical writer collaborates with key stakeholders across business units, contract manufacturing organizations, and functional teams such as Quality, Manufacturing, and Global Regulatory Affairs. dditional responsibilities include supporting regulatory risk mitigation strategies, maintaining current regulatory knowledge, and supporting planning and timeline preparation. Requirement/Must Have:
CMC and CTD authoring experience (Modules 2 and 3). t least five years of experience in the pharmaceutical industry. Experience with document management systems such as Veeva or Documentum (preferred). Working knowledge of cGMPs. Experience with MS Office applications. Excellent interpersonal communication skills. bility to work independently with minimal supervision. Strong organization skills, attention to detail, and self-motivation. Experience:
Experience in pharmaceutical manufacturing or quality control/quality assurance (preferred). Experience with small molecules and some aseptically manufactured products. Medical device experience (preferred). Responsibilities:
Develop and author CMC CTD documents for regulatory submissions. Prepare responses to health authority inquiries and regulatory updates. uthor and evaluate change controls for global regulatory impact. Create technical reports, position papers, XX papers, or SOPs. Ensure regulatory dossier compliance. Collaborate with cross-functional stakeholders and CMOs. Support regulatory risk mitigation strategies. Maintain updated knowledge of SOPs, regulatory guidelines, and ways of working. ssist in planning and timeline preparation. Should Have:
bility to work collaboratively across multidisciplinary teams. Strong communication and stakeholder coordination skills. Skills:
Expertise in CMC and CTD documentation. Knowledge of Veeva or Documentum. Understanding of cGMPs. Strong organizational and writing skills. bility to analyze and interpret regulatory requirements. Qualification And Education:
BS/BA, MS, or PhD in a science or health field such as Biology, Analytical Chemistry, Pharmacy, or a related discipline.